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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name patch, pledget and intracardiac, petp, ptfe, polypropylene
510(k) Number K091626
Device Name CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH
Applicant
CRYOLIFE, INC.
1655 ROBERTS BLVD., N.W.
KENNESAW,  GA  30144
Applicant Contact JOHN FERROS
Correspondent
CRYOLIFE, INC.
1655 ROBERTS BLVD., N.W.
KENNESAW,  GA  30144
Correspondent Contact JOHN FERROS
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received06/03/2009
Decision Date 08/07/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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